Binax, Inc. · Class II · Cleared Apr 14, 2010
| K-number | K090301 |
| Device name | BINAXNOW PBP2A TEST, MODEL 890-000 |
| Applicant | Binax, Inc. |
| Product code | MYI |
| Device class | Class II |
| Decision date | Apr 14, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov